BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA FREEDOM DRIVER

    MDR report key: 7138747 · Received December 21, 2017

    Report

    Report Number
    3003761017-2017-00259
    Event Type
    Malfunction
    Date Received
    December 21, 2017
    Date of Event
    December 14, 2017
    Report Date
    July 16, 2018
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    UDI-DI
    00858000003121
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DRIVER IN "AS RECEIVED" CONDITION PASSED ALL TEST SECTIONS AND PRESSURE PERFORMANCE METRICS ASSOCIATED WITH NORMOTENSIVE AND HYPERTENSIVE SETTINGS. THE CUSTOMER-REPORTED ISSUE OF A FAULT ALARM COULD NOT BE REPRODUCED DURING INVESTIGATION TESTING. THE ROOT CAUSE OF THE CUSTOMER-REPORTED ISSUE CANNOT BE CONCLUSIVELY DETERMINED AS THE DRIVER PERFORMED AS INTENDED WITH NO EVIDENCE OF A DEVICE MALFUNCTION. THIS ISSUE WILL CONTINUE TO BE MONITORED AND TRENDED AS PART OF THE CUSTOMER EXPERIENCE PROCESS. SYNCARDIA HAS COMPLETED ITS EVALUATION AND IS CLOSING THIS FILE. (B)(4) FOLLOW-UP REPORT 1.

    Additional Manufacturer Narrative · 1

    THIS ALLEGED FAILURE MODE POSES A LOW RISK TO THE PATIENT BECAUSE ALTHOUGH THE FREEDOM DRIVER EXHIBITED A FAULT ALARM, IT CONTINUED TO PERFORM ITS LIFE-SUSTAINING FUNCTIONS. THE FREEDOM DRIVER WILL BE RETURNED TO SYNCARDIA FOR EVALUATION. THE RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN A FOLLOW-UP MDR. (B)(4) INITIAL.

    Description of Event or Problem · 1

    THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT THE FREEDOM DRIVER EXHIBITED A FAULT ALARM WHILE SUPPORTING A PATIENT. THE CUSTOMER ALSO REPORTED THAT THE PATIENT WAS SWITCHED TO A BACK-UP FREEDOM DRIVER. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    916282 SYNCARDIA FREEDOM DRIVER EXTERNAL PNUEMATIC DRIVER LOZ SYNCARDIA SYSTEMS, LLC 595000-001 00858000003121

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR